Medical device recalls — page 5
1,617 recent medical device recalls in our current data.
Showing 801–1,000, newest first.
FDA Class II · Medical device · July 8, 2026
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Company / brand: Bard Access Systems recalls
Affected product: OTP5000 THORA/PARA TRAY recall status
Official ID Z-2655-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Company / brand: BD SWITZERLAND SARL recalls
Affected product: MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number recall status
Official ID Z-2654-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
Company / brand: Covidien recalls
Affected product: Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code recall status
Official ID Z-2653-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Company / brand: Carl Zeiss Meditec AG recalls
Affected product: Zeiss Intrabeam Spherical Applicator 1 recall status
Official ID Z-2649-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradual…
Company / brand: Siemens Medical Solutions USA recalls
Affected product: ARTIS icono ceiling recall status
Official ID Z-2648-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session,…
Company / brand: RAYSEARCH LABORATORIES AB recalls
Affected product: RayCare 2024A SP4 recall status
Official ID Z-2647-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session,…
Company / brand: RAYSEARCH LABORATORIES AB recalls
Affected product: RayCare 2024A SP1 recall status
Official ID Z-2646-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritiona…
Company / brand: Medela recalls
Affected product: Brand Name recall status
Official ID Z-2645-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and i…
Company / brand: Accuray Incorporated recalls
Affected product: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer recall status
Official ID Z-2644-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Company / brand: Siemens Medical Solutions USA recalls
Affected product: ARTIS icono floor recall status
Official ID Z-2643-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Company / brand: Siemens Medical Solutions USA recalls
Affected product: ARTIS icono ceiling recall status
Official ID Z-2642-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Company / brand: Siemens Medical Solutions USA recalls
Affected product: ARTIS icono biplane recall status
Official ID Z-2641-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and i…
Company / brand: Accuray Incorporated recalls
Affected product: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer recall status
Official ID Z-2640-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Due to out-of-specification, or potential out-of-specification, levels of endotoxins
Company / brand: TELEFLEX recalls
Affected product: Brand Name recall status
Official ID Z-2639-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Secti…
Company / brand: Baxter Healthcare recalls
Affected product: Adapter for Head Positioning recall status
Official ID Z-2638-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Potential sterile breach of the pouches in which devices are packaged.
Company / brand: Boston Scientific recalls
Affected product: CRE Wireguided 18-20mm 240cm recall status
Official ID Z-2637-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Potential sterile breach of the pouches in which devices are packaged.
Company / brand: Boston Scientific recalls
Affected product: CRE Wireguided 15-18mm 240cm recall status
Official ID Z-2636-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Potential sterile breach of the pouches in which devices are packaged.
Company / brand: Boston Scientific recalls
Affected product: CRE Wireguided 12-15mm 240cm recall status
Official ID Z-2635-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Potential sterile breach of the pouches in which devices are packaged.
Company / brand: Boston Scientific recalls
Affected product: CRE Wireguided 10-12mm 240cm recall status
Official ID Z-2634-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Potential sterile breach of the pouches in which devices are packaged.
Company / brand: Boston Scientific recalls
Affected product: CRE Wireguided 8-10mm 240cm recall status
Official ID Z-2633-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Potential sterile breach of the pouches in which devices are packaged.
Company / brand: Boston Scientific recalls
Affected product: CRE Wireguided 6-8mm 240cm recall status
Official ID Z-2632-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Potential sterile breach of the pouches in which devices are packaged.
Company / brand: Boston Scientific recalls
Affected product: CRE Pro Wireguided 18-20mm 240cm recall status
Official ID Z-2631-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Potential sterile breach of the pouches in which devices are packaged.
Company / brand: Boston Scientific recalls
Affected product: CRE Pro Wireguided 15-18mm 240cm recall status
Official ID Z-2630-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Potential sterile breach of the pouches in which devices are packaged.
Company / brand: Boston Scientific recalls
Affected product: CRE Pro Wireguided 12-15mm 240cm recall status
Official ID Z-2629-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Potential sterile breach of the pouches in which devices are packaged.
Company / brand: Boston Scientific recalls
Affected product: CRE Pro Wireguided 10-12mm 240cm recall status
Official ID Z-2628-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Potential sterile breach of the pouches in which devices are packaged.
Company / brand: Boston Scientific recalls
Affected product: CRE Pro Wireguided 8-10mm 240cm recall status
Official ID Z-2627-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Potential sterile breach of the pouches in which devices are packaged.
Company / brand: Boston Scientific recalls
Affected product: CRE Pro Wireguided 6-8mm 240cm recall status
Official ID Z-2626-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by…
Company / brand: Hamilton Medical AG recalls
Affected product: IntelliCuff recall status
Official ID Z-2625-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedur…
Company / brand: Medtronic Heart Valves Division recalls
Affected product: Medtronic Harmony Delivery Catheter System recall status
Official ID Z-2624-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
Company / brand: Remel recalls
Affected product: GC Agar Base (150mm) 10/PK R04030 recall status
Official ID Z-2623-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization …
Company / brand: Windstone Medical Packaging recalls
Affected product: A M S recall status
Official ID Z-2622-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization …
Company / brand: Windstone Medical Packaging recalls
Affected product: A M S recall status
Official ID Z-2621-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization …
Company / brand: Windstone Medical Packaging recalls
Affected product: A M S recall status
Official ID Z-2620-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization …
Company / brand: Windstone Medical Packaging recalls
Affected product: A M S recall status
Official ID Z-2619-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are posit…
Company / brand: Medacta Usa recalls
Affected product: Short Monobloc Stem Broaches recall status
Official ID Z-2618-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Company / brand: DEPUY (IRELAND) recalls
Affected product: Depuy Synthes recall status
Official ID Z-2617-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Company / brand: DEPUY (IRELAND) recalls
Affected product: Depuy Synthes recall status
Official ID Z-2616-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surface…
Company / brand: Medline Industries recalls
Affected product: Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no recall status
Official ID Z-2615-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
A single lot of expired syringes were distributed due to a distribution system control failure.
Company / brand: Mentor Texas LP recalls
Affected product: SYRINGE LUER LOK 10CC-200/BOX BD Product Code recall status
Official ID Z-2614-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS recall status
Official ID Z-2613-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX recall status
Official ID Z-2612-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OP recall status
Official ID Z-2611-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET recall status
Official ID Z-2610-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ9 recall status
Official ID Z-2609-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE recall status
Official ID Z-2608-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G recall status
Official ID Z-2607-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX recall status
Official ID Z-2606-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The p…
Company / brand: Insulet recalls
Affected product: Omnipod (Eros) Pod recall status
Official ID Z-2605-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The p…
Company / brand: Insulet recalls
Affected product: Omnipod DASH Pod recall status
Official ID Z-2604-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The p…
Company / brand: Insulet recalls
Affected product: Omnipod 5 Pods recall status
Official ID Z-2603-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the p…
Company / brand: Baxter Healthcare recalls
Affected product: Hillrom VOLARA System P recall status
Official ID Z-2551-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the p…
Company / brand: Baxter Healthcare recalls
Affected product: Hillrom VOLARA System P recall status
Official ID Z-2550-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the p…
Company / brand: Baxter Healthcare recalls
Affected product: Hillrom VOLARA P recall status
Official ID Z-2549-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the p…
Company / brand: Baxter Healthcare recalls
Affected product: Hillrom VOLARA System P recall status
Official ID Z-2548-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2547-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2546-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2545-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2544-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2543-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2542-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2541-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2540-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2539-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2538-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2537-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2536-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2535-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2534-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2533-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalati…
Company / brand: Hamilton Medical AG recalls
Affected product: Breathing circuit set recall status
Official ID Z-2463-2026 ·
Official record ↗
FDA Class I · Medical device · July 1, 2026
Potential for thrombus formation during prolonged use of the introducer.
Company / brand: Abiomed recalls
Affected product: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall status
Official ID Z-2602-2026 ·
Official record ↗
FDA Class I · Medical device · July 1, 2026
Potential for thrombus formation during prolonged use of the introducer.
Company / brand: Abiomed recalls
Affected product: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall status
Official ID Z-2601-2026 ·
Official record ↗
FDA Class I · Medical device · July 1, 2026
Potential for thrombus formation during prolonged use of the introducer.
Company / brand: Abiomed recalls
Affected product: Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP recall status
Official ID Z-2600-2026 ·
Official record ↗
FDA Class I · Medical device · July 1, 2026
Potential for thrombus formation during prolonged use of the introducer.
Company / brand: Abiomed recalls
Affected product: Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP recall status
Official ID Z-2599-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Company / brand: Medline Industries recalls
Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status
Official ID Z-2596-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Company / brand: Medline Industries recalls
Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status
Official ID Z-2595-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Company / brand: Medline Industries recalls
Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status
Official ID Z-2594-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Company / brand: Medline Industries recalls
Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status
Official ID Z-2593-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Company / brand: Medline Industries recalls
Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status
Official ID Z-2592-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Company / brand: Medline Industries recalls
Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status
Official ID Z-2591-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Company / brand: Medline Industries recalls
Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status
Official ID Z-2590-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Company / brand: Medline Industries recalls
Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status
Official ID Z-2589-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Company / brand: Medline Industries recalls
Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status
Official ID Z-2588-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Company / brand: Medline Industries recalls
Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status
Official ID Z-2587-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Company / brand: Medline Industries recalls
Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status
Official ID Z-2586-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Company / brand: Medline Industries recalls
Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status
Official ID Z-2585-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Company / brand: Medline Industries recalls
Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status
Official ID Z-2584-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Company / brand: Medline Industries recalls
Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status
Official ID Z-2583-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Company / brand: Medline Industries recalls
Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status
Official ID Z-2582-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Company / brand: Medline Industries recalls
Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status
Official ID Z-2581-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Company / brand: Boston Scientific recalls
Affected product: Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall status
Official ID Z-2580-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PI…
Company / brand: Philips North America recalls
Affected product: Philips Telemetry Monitor 5500 1 recall status
Official ID Z-2579-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
Company / brand: Zimmer recalls
Affected product: Brand Name recall status
Official ID Z-2578-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the can…
Company / brand: Medtronic Perfusion Systems recalls
Affected product: Octopus 4 Tissue Stabilizer recall status
Official ID Z-2577-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the can…
Company / brand: Medtronic Perfusion Systems recalls
Affected product: Octopus Evolution AS Tissue Stabilizer recall status
Official ID Z-2576-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the can…
Company / brand: Medtronic Perfusion Systems recalls
Affected product: Octopus Evolution Tissue Stabilizer recall status
Official ID Z-2575-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies …
Company / brand: Dexcom recalls
Affected product: Brand Name recall status
Official ID Z-2574-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2573-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2572-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2571-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2570-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2569-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2568-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2567-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2566-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2565-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2564-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2563-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2562-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2561-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2560-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2559-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2558-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2557-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2556-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Company / brand: SURGIFY MEDICAL OY recalls
Affected product: Surgify Halo recall status
Official ID Z-2555-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Software anomaly that causes a false display of error code 5018.
Company / brand: IPG Medical recalls
Affected product: Thuvera Laser Console recall status
Official ID Z-2554-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches…
Company / brand: GE Medical Systems SCS recalls
Affected product: GE Healthcare AW Server 3 recall status
Official ID Z-2553-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be …
Company / brand: Stryker Neurovascular recalls
Affected product: INZONE DETACHMENT SYSTEM recall status
Official ID Z-2552-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
Company / brand: Acumed recalls
Affected product: Acumed Hexalob Screw various sizes recall status
Official ID Z-2532-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Company / brand: Zimmer recalls
Affected product: Off-Axis Alliance Glenoid recall status
Official ID Z-2531-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Company / brand: Zimmer recalls
Affected product: Off-Axis Alliance Glenoid recall status
Official ID Z-2530-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Company / brand: Zimmer recalls
Affected product: Off-Axis Comprehensive Shoulder System recall status
Official ID Z-2529-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Company / brand: Zimmer recalls
Affected product: Off-Axis Comprehensive Shoulder System recall status
Official ID Z-2528-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Company / brand: Zimmer recalls
Affected product: Off-Axis Comprehensive Shoulder System Small recall status
Official ID Z-2527-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-…
Company / brand: PFM MEDICAL recalls
Affected product: Multi-Snare Set recall status
Official ID Z-2526-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the back…
Company / brand: Ventec Life Systems recalls
Affected product: VOCSN+Pro package recall status
Official ID Z-2525-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
Company / brand: TMJ Solutions recalls
Affected product: TMJ Bilateral Implants recall status
Official ID Z-2524-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of spe…
Company / brand: Philips North America recalls
Affected product: Philips Avalon Fetal Monitor recall status
Official ID Z-2523-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of spe…
Company / brand: Philips North America recalls
Affected product: Philips Avalon Fetal Monitor recall status
Official ID Z-2522-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engage…
Company / brand: Intuitive Surgical recalls
Affected product: Da Vinci ASSY recall status
Official ID Z-2521-2026 ·
Official record ↗
FDA Class I · Medical device · July 1, 2026
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were rec…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2455-2026 ·
Official record ↗
FDA Class I · Medical device · July 1, 2026
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were rec…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2454-2026 ·
Official record ↗
FDA Class I · Medical device · July 1, 2026
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were rec…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2453-2026 ·
Official record ↗
FDA Class I · Medical device · July 1, 2026
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were rec…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-2452-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Due to 11 volt Backup Battery failures.
Company / brand: Thoratec recalls
Affected product: Brand Name recall status
Official ID Z-2520-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Due to 11 volt Backup Battery failures.
Company / brand: Thoratec recalls
Affected product: Brand Name recall status
Official ID Z-2519-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Due to 11 volt Backup Battery failures.
Company / brand: Thoratec recalls
Affected product: Brand Name recall status
Official ID Z-2518-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Due to unsealed portions of pouches.
Company / brand: Merit Medical Systems recalls
Affected product: Splashwire Hydrophilic Guide Wire recall status
Official ID Z-2517-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By D…
Company / brand: Inspire Medical Systems recalls
Affected product: Brand Name recall status
Official ID Z-2516-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By D…
Company / brand: Inspire Medical Systems recalls
Affected product: Brand Name recall status
Official ID Z-2515-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has …
Company / brand: BD SWITZERLAND SARL recalls
Affected product: BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code recall status
Official ID Z-2514-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfu…
Company / brand: Beta Bionics recalls
Affected product: iLet Bionic Pancreas recall status
Official ID Z-2513-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
Company / brand: Staar Surgical AG recalls
Affected product: Product Name recall status
Official ID Z-2509-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2508-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2507-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2506-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY recall status
Official ID Z-2505-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2504-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as BASIC GYN recall status
Official ID Z-2503-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2502-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2501-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2500-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2499-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2498-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT recall status
Official ID Z-2497-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2496-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2495-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2494-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2493-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2492-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2491-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2490-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2489-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2488-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as CH OPEN HEART recall status
Official ID Z-2487-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2486-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Medical Procedure Kits labeled as recall status
Official ID Z-2485-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag recall status
Official ID Z-2484-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag recall status
Official ID Z-2483-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Urethral Catheterization Tray and Bag recall status
Official ID Z-2482-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Pre-connected Urethral Catheterization Tray and Bag recall status
Official ID Z-2481-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Urethral Catheterization Tray recall status
Official ID Z-2480-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Company / brand: Medline Industries recalls
Affected product: MEDLINE Urethral Catheter recall status
Official ID Z-2479-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.
Company / brand: MITO RED LIGHT recalls
Affected product: Mito Red Light recall status
Official ID Z-2478-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during tr…
Company / brand: GE Medical Systems recalls
Affected product: Giraffe OmniBed Field Replaceable Unit (FRU) recall status
Official ID Z-2477-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during tr…
Company / brand: GE Medical Systems recalls
Affected product: Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1 recall status
Official ID Z-2476-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during tr…
Company / brand: GE Medical Systems recalls
Affected product: Giraffe OmniBed recall status
Official ID Z-2475-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Potential for overpressure alerts.
Company / brand: ConMed recalls
Affected product: ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip recall status
Official ID Z-2474-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Potential for overpressure alerts.
Company / brand: ConMed recalls
Affected product: ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall status
Official ID Z-2473-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Potential for overpressure alerts.
Company / brand: ConMed recalls
Affected product: ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip recall status
Official ID Z-2472-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Potential for overpressure alerts.
Company / brand: ConMed recalls
Affected product: ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall status
Official ID Z-2471-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Potential for overpressure alerts.
Company / brand: ConMed recalls
Affected product: ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall status
Official ID Z-2470-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Potential for overpressure alerts.
Company / brand: ConMed recalls
Affected product: ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall status
Official ID Z-2469-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Potential for overpressure alerts.
Company / brand: ConMed recalls
Affected product: ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall status
Official ID Z-2468-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Potential for overpressure alerts.
Company / brand: ConMed recalls
Affected product: ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall status
Official ID Z-2467-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Potential for overpressure alerts.
Company / brand: ConMed recalls
Affected product: ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip recall status
Official ID Z-2466-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Potential for overpressure alerts.
Company / brand: ConMed recalls
Affected product: ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip recall status
Official ID Z-2465-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Potential for overpressure alerts.
Company / brand: ConMed recalls
Affected product: ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip recall status
Official ID Z-2464-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon…
Company / brand: Howmedica Osteonics recalls
Affected product: TRI TS BASEPLATE SIZE 4 recall status
Official ID Z-2462-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon…
Company / brand: Howmedica Osteonics recalls
Affected product: TRI TS BASEPLATE SIZE 3 recall status
Official ID Z-2461-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Assayed Whole blood control contains labeling with incorrect performance range.
Company / brand: Accriva Diagnostics recalls
Affected product: directCHECK ACT-LR whole blood quality control recall status
Official ID Z-2460-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet end…
Company / brand: AMD Medicom recalls
Affected product: Ritmed Neurological Sponges recall status
Official ID Z-2459-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet end…
Company / brand: AMD Medicom recalls
Affected product: Ritmed Neurological Sponges recall status
Official ID Z-2458-2026 ·
Official record ↗
FDA Class I · Medical device · June 24, 2026
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Company / brand: Abiomed recalls
Affected product: Impella CP Set with SmartAssist recall status
Official ID Z-2457-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equ…
Company / brand: Smith & Nephew recalls
Affected product: TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16 recall status
Official ID Z-2456-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Company / brand: Medtronic Navigation recalls
Affected product: Medtronic O-arm O2 Imaging System recall status
Official ID Z-2451-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Company / brand: Steris recalls
Affected product: ALYON Surgical Lighting System recall status
Official ID Z-2450-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Company / brand: Steris recalls
Affected product: HarmonyAIR A-Series Surgical Lighting System recall status
Official ID Z-2449-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
Company / brand: Steris recalls
Affected product: HarmonyAIR A-Series Surgical Lighting System recall status
Official ID Z-2448-2026 ·
Official record ↗
Sources last checked October 22, 2026 at 12:00 PM UTC.