FDA Class II · Medical device · July 15, 2026
Aquacel Ag Surgical SP REF recall — ConvaTec, Inc
Surgical dressing manufactured out of specification (greater thickness).
Official ID Z-2677-2026 · Official notice ↗
Medical device recalls
200 recent Medical device recalls in our current data.
FDA Class II · Medical device · July 15, 2026
GSP Neonatal GALT Kit recall — WALLAC OY
Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.
Official ID Z-2713-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
KL Owen Custom Orthodontic Solution recall — Klowen Braces
A product error defect may cause incorrect bracket placement.
Official ID Z-2699-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
MiniMed 780G Insulin Pump recall — Medtronic MiniMed, Inc.
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error me…
Official ID Z-2698-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
Olympus Single Use Distal Cover recall — Olympus Corporation of the Americas
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
Official ID Z-2676-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
Brand Name recall — CMR SURGICAL LIMITED
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Official ID Z-2717-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
Medline Convenience Kits recall — Medline Industries, LP
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm ge…
Official ID Z-2695-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
Atellica CH Enzymatic Hemoglobin A1c (A1c_E) recall — Siemens Healthcare Diagnostics, Inc.
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patien…
Official ID Z-2703-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
Brand Name recall — Elekta, Inc.
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Official ID Z-2710-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
5008X Blood Tubing Set recall — Fresenius Medical Care Holdings, Inc.
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
Official ID Z-2702-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
Brand Name recall — Elekta, Inc.
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Official ID Z-2711-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
Brand Name recall — Elekta, Inc.
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Official ID Z-2712-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
TMINI Femur Tracking Array REF 109003 UDI-DI code recall — Think Surgical, Inc.
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
Official ID Z-2716-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
VITEK 2 AST-N447 TEST KIT Product reference 424620 recall — Biomerieux Inc
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Official ID Z-2715-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
Intracept Access Instruments recall — Boston Scientific Neuromodulation Corporation
Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to…
Official ID Z-2694-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
Medline Convenience Kits recall — Medline Industries, LP
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm ge…
Official ID Z-2697-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
Brand Name recall — Encore Medical, LP
Due to packaging discrepancy with incorrect product size mixed up.
Official ID Z-2700-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
Brand Name recall — Encore Medical, LP
Due to packaging discrepancy with incorrect product size mixed up.
Official ID Z-2701-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
Medline Convenience Kits recall — Medline Industries, LP
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm ge…
Official ID Z-2696-2026 · Official notice ↗
FDA Class II · Medical device · July 15, 2026
OmniTract Surgical Retractor System recall — Integra LifeSciences Corp. (NeuroSciences)
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 …
Official ID Z-2714-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
GC Agar Base (150mm) 10/PK R04030 recall — Remel, Inc
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
Official ID Z-2623-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ9 recall — Medline Industries, LP
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…
Official ID Z-2609-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
RayCare 2024A SP1 recall — RAYSEARCH LABORATORIES AB
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,…
Official ID Z-2646-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code recall — Bard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Official ID Z-2656-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G recall — Medline Industries, LP
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…
Official ID Z-2607-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CRE Pro Wireguided 12-15mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2629-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Brand Name recall — TELEFLEX LLC
Due to out-of-specification, or potential out-of-specification, levels of endotoxins
Official ID Z-2639-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2542-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Radius VSM ECG pre-connected Set recall — Masimo Corporation
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate pati…
Official ID Z-2670-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen recall — Bard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Official ID Z-2661-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2538-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2539-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OP recall — Medline Industries, LP
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…
Official ID Z-2611-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Zeiss Intrabeam Spherical Applicator 1 recall — Carl Zeiss Meditec AG
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Official ID Z-2649-2026 · Official notice ↗
FDA Class I · Medical device · July 8, 2026
Omnipod 5 Pods recall — Insulet Corporation
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…
Official ID Z-2603-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE recall — Medline Industries, LP
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…
Official ID Z-2608-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code recall — Bard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Official ID Z-2662-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2541-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2540-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code recall — Bard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Official ID Z-2667-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code recall — Bard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Official ID Z-2657-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code recall — Bard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Official ID Z-2664-2026 · Official notice ↗
FDA Class I · Medical device · July 8, 2026
Hillrom VOLARA System P recall — Baxter Healthcare Corporation
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…
Official ID Z-2550-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2537-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX recall — Medline Industries, LP
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…
Official ID Z-2612-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2534-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
RayCare 2024A SP4 recall — RAYSEARCH LABORATORIES AB
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,…
Official ID Z-2647-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CRE Pro Wireguided 10-12mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2628-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
ARTIS icono ceiling recall — Siemens Medical Solutions USA, Inc
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…
Official ID Z-2648-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Brand Name recall — Medela Inc
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…
Official ID Z-2645-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC recall — Bard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Official ID Z-2659-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CRE Pro Wireguided 15-18mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2630-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code recall — Covidien LLC
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
Official ID Z-2653-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
SYRINGE LUER LOK 10CC-200/BOX BD Product Code recall — Mentor Texas LP
A single lot of expired syringes were distributed due to a distribution system control failure.
Official ID Z-2614-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region recall — W L Gore & Associates, Inc.
Due to catheter separation
Official ID Z-2672-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CRE Pro Wireguided 6-8mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2626-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2533-2026 · Official notice ↗
FDA Class I · Medical device · July 8, 2026
Breathing circuit set recall — Hamilton Medical AG
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…
Official ID Z-2463-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CRE Wireguided 8-10mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2633-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code recall — Bard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Official ID Z-2658-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer recall — Accuray Incorporated
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…
Official ID Z-2644-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS recall — Medline Industries, LP
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…
Official ID Z-2613-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Adapter for Head Positioning recall — Baxter Healthcare Corporation
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…
Official ID Z-2638-2026 · Official notice ↗
FDA Class I · Medical device · July 8, 2026
Omnipod DASH Pod recall — Insulet Corporation
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…
Official ID Z-2604-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2544-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CRE Wireguided 12-15mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2635-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CRE Wireguided 15-18mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2636-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2535-2026 · Official notice ↗
FDA Class I · Medical device · July 8, 2026
A M S recall — Windstone Medical Packaging, Inc.
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 …
Official ID Z-2622-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Brand Name recall — Zimmer Surgical Inc
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insigni…
Official ID Z-2674-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
ARTIS icono floor recall — Siemens Medical Solutions USA, Inc
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Official ID Z-2643-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Depuy Synthes recall — DEPUY (IRELAND)
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Official ID Z-2617-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
OTP5000 THORA/PARA TRAY recall — Bard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Official ID Z-2655-2026 · Official notice ↗
FDA Class I · Medical device · July 8, 2026
A M S recall — Windstone Medical Packaging, Inc.
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 …
Official ID Z-2620-2026 · Official notice ↗
FDA Class I · Medical device · July 8, 2026
Hillrom VOLARA System P recall — Baxter Healthcare Corporation
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…
Official ID Z-2551-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code recall — Bard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Official ID Z-2665-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CRE Wireguided 6-8mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2632-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code recall — Bard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Official ID Z-2663-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CRE Wireguided 18-20mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2637-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Depuy Synthes recall — DEPUY (IRELAND)
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Official ID Z-2616-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX recall — Medline Industries, LP
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…
Official ID Z-2606-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET recall — Medline Industries, LP
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…
Official ID Z-2610-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer recall — Accuray Incorporated
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…
Official ID Z-2640-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2547-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Radius VSM Disposable NIBP Cuff recall — Masimo Corporation
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate pati…
Official ID Z-2671-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CRE Pro Wireguided 8-10mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2627-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code recall — Bard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Official ID Z-2668-2026 · Official notice ↗
FDA Class I · Medical device · July 8, 2026
Medtronic Harmony Delivery Catheter System recall — Medtronic Heart Valves Division
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…
Official ID Z-2624-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
ARTIS icono biplane recall — Siemens Medical Solutions USA, Inc
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Official ID Z-2641-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2543-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2546-2026 · Official notice ↗
FDA Class I · Medical device · July 8, 2026
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no recall — Medline Industries, LP
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…
Official ID Z-2615-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Solar GI System (Water Perfusion) recall — Laborie Medical Technologies Corp
Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the h…
Official ID Z-2669-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CRE Wireguided 10-12mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2634-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code recall — Bard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Official ID Z-2666-2026 · Official notice ↗
FDA Class I · Medical device · July 8, 2026
A M S recall — Windstone Medical Packaging, Inc.
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 …
Official ID Z-2619-2026 · Official notice ↗
FDA Class I · Medical device · July 8, 2026
A M S recall — Windstone Medical Packaging, Inc.
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 …
Official ID Z-2621-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Brand Name recall — Zimmer Surgical Inc
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insigni…
Official ID Z-2673-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
CRE Pro Wireguided 18-20mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2631-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Short Monobloc Stem Broaches recall — Medacta Usa Inc
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…
Official ID Z-2618-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number recall — BD SWITZERLAND SARL
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Official ID Z-2654-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
IntelliCuff recall — Hamilton Medical AG
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…
Official ID Z-2625-2026 · Official notice ↗
FDA Class I · Medical device · July 8, 2026
Omnipod (Eros) Pod recall — Insulet Corporation
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…
Official ID Z-2605-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Co recall — Bard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Official ID Z-2660-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
ARTIS icono ceiling recall — Siemens Medical Solutions USA, Inc
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Official ID Z-2642-2026 · Official notice ↗
FDA Class I · Medical device · July 8, 2026
Hillrom VOLARA System P recall — Baxter Healthcare Corporation
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…
Official ID Z-2548-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2536-2026 · Official notice ↗
FDA Class II · Medical device · July 8, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2545-2026 · Official notice ↗
FDA Class I · Medical device · July 8, 2026
Hillrom VOLARA P recall — Baxter Healthcare Corporation
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…
Official ID Z-2549-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2568-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Brand Name recall — Dexcom, Inc.
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 …
Official ID Z-2574-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2558-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Off-Axis Comprehensive Shoulder System recall — Zimmer, Inc.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Official ID Z-2528-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
VOCSN+Pro package recall — Ventec Life Systems, Inc.
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…
Official ID Z-2525-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2590-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2591-2026 · Official notice ↗
FDA Class I · Medical device · July 1, 2026
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall — Abiomed, Inc.
Potential for thrombus formation during prolonged use of the introducer.
Official ID Z-2601-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2562-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2587-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Philips Avalon Fetal Monitor recall — Philips North America Llc
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…
Official ID Z-2522-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2561-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2572-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Octopus Evolution AS Tissue Stabilizer recall — Medtronic Perfusion Systems
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…
Official ID Z-2576-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Off-Axis Alliance Glenoid recall — Zimmer, Inc.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Official ID Z-2531-2026 · Official notice ↗
FDA Class I · Medical device · July 1, 2026
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP recall — Abiomed, Inc.
Potential for thrombus formation during prolonged use of the introducer.
Official ID Z-2600-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2565-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
INZONE DETACHMENT SYSTEM recall — Stryker Neurovascular
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 …
Official ID Z-2552-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Da Vinci ASSY recall — Intuitive Surgical, Inc.
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…
Official ID Z-2521-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Octopus 4 Tissue Stabilizer recall — Medtronic Perfusion Systems
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…
Official ID Z-2577-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2566-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2582-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall — Boston Scientific Corporation
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Official ID Z-2580-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Thuvera Laser Console recall — IPG Medical Corporation
Software anomaly that causes a false display of error code 5018.
Official ID Z-2554-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Brand Name recall — Zimmer, Inc.
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
Official ID Z-2578-2026 · Official notice ↗
FDA Class I · Medical device · July 1, 2026
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP recall — Abiomed, Inc.
Potential for thrombus formation during prolonged use of the introducer.
Official ID Z-2599-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2557-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2592-2026 · Official notice ↗
FDA Class I · Medical device · July 1, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2452-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Multi-Snare Set recall — PFM MEDICAL INC.
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-…
Official ID Z-2526-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2559-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2585-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2581-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2594-2026 · Official notice ↗
FDA Class I · Medical device · July 1, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2455-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2588-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2570-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2595-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
GE Healthcare AW Server 3 recall — GE Medical Systems SCS
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…
Official ID Z-2553-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Octopus Evolution Tissue Stabilizer recall — Medtronic Perfusion Systems
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…
Official ID Z-2575-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Philips Avalon Fetal Monitor recall — Philips North America Llc
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…
Official ID Z-2523-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2556-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2564-2026 · Official notice ↗
FDA Class I · Medical device · July 1, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2454-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
TMJ Bilateral Implants recall — TMJ Solutions Inc
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.
Official ID Z-2524-2026 · Official notice ↗
FDA Class I · Medical device · July 1, 2026
Medline Convenience Kits recall — Medline Industries, LP
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…
Official ID Z-2453-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2569-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2584-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2589-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2573-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2555-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2567-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2560-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2586-2026 · Official notice ↗
FDA Class I · Medical device · July 1, 2026
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall — Abiomed, Inc.
Potential for thrombus formation during prolonged use of the introducer.
Official ID Z-2602-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2593-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2583-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2596-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Off-Axis Alliance Glenoid recall — Zimmer, Inc.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Official ID Z-2530-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Acumed Hexalob Screw various sizes recall — Acumed LLC
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
Official ID Z-2532-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Off-Axis Comprehensive Shoulder System Small recall — Zimmer, Inc.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Official ID Z-2527-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2563-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Surgify Halo recall — SURGIFY MEDICAL OY
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2571-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Off-Axis Comprehensive Shoulder System recall — Zimmer, Inc.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Official ID Z-2529-2026 · Official notice ↗
FDA Class II · Medical device · July 1, 2026
Philips Telemetry Monitor 5500 1 recall — Philips North America Llc
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…
Official ID Z-2579-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2486-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
Medtronic O-arm O2 Imaging System recall — Medtronic Navigation, Inc.-Boxborough
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Official ID Z-2451-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
Brand Name recall — Inspire Medical Systems Inc.
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…
Official ID Z-2516-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2496-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
MEDLINE Medical Procedure Kits labeled as CH OPEN HEART recall — Medline Industries, LP
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2487-2026 · Official notice ↗
FDA Class I · Medical device · June 24, 2026
Description/REF recall — ARROW INTERNATIONAL, LLC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo…
Official ID Z-2379-2026 · Official notice ↗
FDA Class I · Medical device · June 24, 2026
Description/REF recall — ARROW INTERNATIONAL, LLC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo…
Official ID Z-2371-2026 · Official notice ↗
FDA Class I · Medical device · June 24, 2026
Impella CP Set with SmartAssist recall — Abiomed, Inc.
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.
Official ID Z-2457-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
TRI TS BASEPLATE SIZE 3 recall — Howmedica Osteonics Corp.
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…
Official ID Z-2461-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
Medline convenience kits recall — Medline Industries, LP
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2438-2026 · Official notice ↗
FDA Class I · Medical device · June 24, 2026
Description/REF recall — ARROW INTERNATIONAL, LLC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo…
Official ID Z-2388-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2485-2026 · Official notice ↗
FDA Class I · Medical device · June 24, 2026
Description/REF recall — ARROW INTERNATIONAL, LLC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo…
Official ID Z-2385-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
Medline convenience kits recall — Medline Industries, LP
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2434-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
Brand Name recall — Thoratec LLC
Due to 11 volt Backup Battery failures.
Official ID Z-2519-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
Medline convenience kits recall — Medline Industries, LP
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2436-2026 · Official notice ↗
FDA Class I · Medical device · June 24, 2026
Description/REF recall — ARROW INTERNATIONAL, LLC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo…
Official ID Z-2386-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip recall — ConMed Corporation
Potential for overpressure alerts.
Official ID Z-2466-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
Brand Name recall — Thoratec LLC
Due to 11 volt Backup Battery failures.
Official ID Z-2518-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall — ConMed Corporation
Potential for overpressure alerts.
Official ID Z-2471-2026 · Official notice ↗
FDA Class I · Medical device · June 24, 2026
Description/REF recall — ARROW INTERNATIONAL, LLC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo…
Official ID Z-2377-2026 · Official notice ↗
FDA Class I · Medical device · June 24, 2026
Description/REF recall — ARROW INTERNATIONAL, LLC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo…
Official ID Z-2370-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall — ConMed Corporation
Potential for overpressure alerts.
Official ID Z-2473-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
Medline convenience kits recall — Medline Industries, LP
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2431-2026 · Official notice ↗
FDA Class II · Medical device · June 24, 2026
MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2502-2026 · Official notice ↗
FDA Class I · Medical device · June 24, 2026
Description/REF recall — ARROW INTERNATIONAL, LLC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo…
Official ID Z-2387-2026 · Official notice ↗
Verify with the official sources:
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (vehicles aggregated here; car seats & tires not yet)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & egg products ↗ (not yet aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
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Last checked July 23, 2026 at 9:52 PM UTC.