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 ↗
300 recent recalls from the U.S. Food & Drug Administration in our current data (last 90 days).
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Official ID Z-2717-2026 · Official notice ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
Due to packaging discrepancy with incorrect product size mixed up.
Official ID Z-2701-2026 · Official notice ↗
Due to packaging discrepancy with incorrect product size mixed up.
Official ID Z-2700-2026 · Official notice ↗
A product error defect may cause incorrect bracket placement.
Official ID Z-2699-2026 · Official notice ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
Surgical dressing manufactured out of specification (greater thickness).
Official ID Z-2677-2026 · Official notice ↗
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 ↗
Undeclared Peanut. High Valley Orchard Chocolate Covered Raisins contains unintended undeclared peanut due to mis-packaging.
Official ID H-1150-2026 · Official notice ↗
Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Fillet sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the pote…
Official ID H-1149-2026 · Official notice ↗
Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Deluxe With Bacon sandwich. Raw breaded chicken patties pose a risk of foodborne illness due …
Official ID H-1148-2026 · Official notice ↗
Foreign material: small metal pieces
Official ID H-1147-2026 · Official notice ↗
The product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3.
Official ID H-1146-2026 · Official notice ↗
Undeclared Allergen (Soy)
Official ID H-1145-2026 · Official notice ↗
Potential contamination with Salmonella
Official ID H-1144-2026 · Official notice ↗
undeclared soy
Official ID H-1143-2026 · Official notice ↗
Undeclared Sesame allergen
Official ID H-1142-2026 · Official notice ↗
Undeclared Sesame allergen
Official ID H-1141-2026 · Official notice ↗
Undeclared Sesame allergen
Official ID H-1140-2026 · Official notice ↗
Undeclared Sesame allergen
Official ID H-1139-2026 · Official notice ↗
Undeclared Sesame allergen
Official ID H-1138-2026 · Official notice ↗
cGMP deviations
Official ID D-0691-2026 · Official notice ↗
Lack of Sterility Assurance
Official ID D-0674-2026 · Official notice ↗
Lack of Sterility Assurance
Official ID D-0673-2026 · Official notice ↗
Lack of Sterility Assurance
Official ID D-0672-2026 · Official notice ↗
Lack of Sterility Assurance
Official ID D-0671-2026 · Official notice ↗
Subpotent drug
Official ID D-0670-2026 · Official notice ↗
Subpotent drug
Official ID D-0669-2026 · Official notice ↗
Subpotent drug
Official ID D-0668-2026 · Official notice ↗
Subpotent drug
Official ID D-0667-2026 · Official notice ↗
Subpotent drug
Official ID D-0666-2026 · Official notice ↗
Subpotent drug
Official ID D-0665-2026 · Official notice ↗
Failed Impurities/Degradation Specifications
Official ID D-0664-2026 · Official notice ↗
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Official ID D-0663-2026 · Official notice ↗
Failed Impurities/Degradation Specifications
Official ID D-0662-2026 · Official notice ↗
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Official ID Event 99296 (recall # pending) · Official notice ↗
undeclared colors (yellow#5)
Official ID Event 99205 (recall # pending) · Official notice ↗
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 ↗
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 ↗
Due to catheter separation
Official ID Z-2672-2026 · Official notice ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Official ID Z-2654-2026 · Official notice ↗
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 ↗
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Official ID Z-2649-2026 · Official notice ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
Due to out-of-specification, or potential out-of-specification, levels of endotoxins
Official ID Z-2639-2026 · Official notice ↗
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 ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2637-2026 · Official notice ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2636-2026 · Official notice ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2635-2026 · Official notice ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2634-2026 · Official notice ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2633-2026 · Official notice ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2632-2026 · Official notice ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2631-2026 · Official notice ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2630-2026 · Official notice ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2629-2026 · Official notice ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2628-2026 · Official notice ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2627-2026 · Official notice ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2626-2026 · Official notice ↗
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 ↗
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 ↗
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
Official ID Z-2623-2026 · Official notice ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Official ID Z-2617-2026 · Official notice ↗
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Official ID Z-2616-2026 · Official notice ↗
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 ↗
A single lot of expired syringes were distributed due to a distribution system control failure.
Official ID Z-2614-2026 · Official notice ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
Elevated coliforms
Official ID H-1151-2026 · Official notice ↗
Product may be contaminated with Clostridium botulinum.
Official ID H-1137-2026 · Official notice ↗
Undeclared allergen (milk) and process deviation (product not held under refrigeration as required)
Official ID H-1136-2026 · Official notice ↗
Dietary supplement product Vista MAX contains undeclared Yellow#5.
Official ID H-1135-2026 · Official notice ↗
Dietary supplement product Ocular Plus contains undeclared Yellow#5.
Official ID H-1134-2026 · Official notice ↗
Potential contamination with plastic material
Official ID H-1130-2026 · Official notice ↗
Potential contamination with plastic material
Official ID H-1129-2026 · Official notice ↗
Product may be contaminated with Salmonella Typhimurium
Official ID H-1128-2026 · Official notice ↗
Undeclared peanuts.
Official ID H-1125-2026 · Official notice ↗
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Official ID D-0699-2026 · Official notice ↗
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Official ID D-0698-2026 · Official notice ↗
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Official ID D-0697-2026 · Official notice ↗
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Official ID D-0696-2026 · Official notice ↗
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Official ID D-0695-2026 · Official notice ↗
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Official ID D-0694-2026 · Official notice ↗
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Official ID D-0693-2026 · Official notice ↗
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Official ID D-0692-2026 · Official notice ↗
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Official ID D-0676-2026 · Official notice ↗
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Official ID D-0675-2026 · Official notice ↗
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Official ID D-0661-2026 · Official notice ↗
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Official ID D-0660-2026 · Official notice ↗
Lack of Assurance of Sterility
Official ID D-0659-2026 · Official notice ↗
Lack of Assurance of Sterility
Official ID D-0658-2026 · Official notice ↗
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Official ID D-0657-2026 · Official notice ↗
Subpotent Drug
Official ID D-0656-2026 · Official notice ↗
Presence of Foreign Substance
Official ID D-0655-2026 · Official notice ↗
Failed Impurities/Degradation Specifications
Official ID D-0654-2026 · Official notice ↗
Lack of assurance of Sterility:
Official ID D-0653-2026 · Official notice ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Official ID D-0652-2026 · Official notice ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Official ID D-0651-2026 · Official notice ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Official ID D-0650-2026 · Official notice ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Official ID D-0649-2026 · Official notice ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Official ID D-0648-2026 · Official notice ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Official ID D-0647-2026 · Official notice ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Official ID D-0646-2026 · Official notice ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Official ID D-0645-2026 · Official notice ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Official ID D-0644-2026 · Official notice ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Official ID D-0643-2026 · Official notice ↗
Potential for thrombus formation during prolonged use of the introducer.
Official ID Z-2602-2026 · Official notice ↗
Potential for thrombus formation during prolonged use of the introducer.
Official ID Z-2601-2026 · Official notice ↗
Potential for thrombus formation during prolonged use of the introducer.
Official ID Z-2600-2026 · Official notice ↗
Potential for thrombus formation during prolonged use of the introducer.
Official ID Z-2599-2026 · Official notice ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2573-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2572-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2571-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2570-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2569-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2568-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2567-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2566-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2565-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2564-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2563-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2562-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2561-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2560-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2559-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2558-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2557-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2556-2026 · Official notice ↗
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official ID Z-2555-2026 · Official notice ↗
Software anomaly that causes a false display of error code 5018.
Official ID Z-2554-2026 · Official notice ↗
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 ↗
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 ↗
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
Official ID Z-2532-2026 · Official notice ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
Undeclared allergen, sesame.
Official ID H-1133-2026 · Official notice ↗
Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.
Official ID H-1132-2026 · Official notice ↗
Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.
Official ID H-1131-2026 · Official notice ↗
Undeclared allergens: Milk and Soy
Official ID H-1124-2026 · Official notice ↗
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Official ID H-1123-2026 · Official notice ↗
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Official ID H-1122-2026 · Official notice ↗
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Official ID H-1121-2026 · Official notice ↗
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Official ID H-1120-2026 · Official notice ↗
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Official ID H-1119-2026 · Official notice ↗
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Official ID H-1118-2026 · Official notice ↗
Potential presence of Salmonella.
Official ID H-1117-2026 · Official notice ↗
Potential presence of Salmonella.
Official ID H-1116-2026 · Official notice ↗
Potential presence of Salmonella.
Official ID H-1115-2026 · Official notice ↗
Potential presence of Salmonella.
Official ID H-1114-2026 · Official notice ↗
Potential presence of Salmonella.
Official ID H-1113-2026 · Official notice ↗
Potential presence of Salmonella.
Official ID H-1112-2026 · Official notice ↗
Incorrect Product Label; Roast Beef and Swiss closed face sub sandwich labeled as Turkey and Cheddar closed face sub sandwich
Official ID H-1111-2026 · Official notice ↗
Undeclared colors (FD&C Yellow 5 and FD&C Red 40).
Official ID H-1110-2026 · Official notice ↗
Potential Salmonella contamination
Official ID H-1106-2026 · Official notice ↗
Potential Salmonella contamination
Official ID H-1105-2026 · Official notice ↗
Potential Salmonella contamination
Official ID H-1104-2026 · Official notice ↗
Potential Salmonella contamination
Official ID H-1103-2026 · Official notice ↗
Potential Salmonella contamination.
Official ID H-1102-2026 · Official notice ↗
Potential Salmonella contamination.
Official ID H-1101-2026 · Official notice ↗
Potential Salmonella contamination
Official ID H-1100-2026 · Official notice ↗
Potential Salmonella contamination
Official ID H-1099-2026 · Official notice ↗
Potential Salmonella contamination
Official ID H-1098-2026 · Official notice ↗
Potential Salmonella contamination
Official ID H-1097-2026 · Official notice ↗
Potential Salmonella contamination
Official ID H-1096-2026 · Official notice ↗
potential salmonella contamination
Official ID H-1095-2026 · Official notice ↗
Product not adequately pasteurized
Official ID H-1094-2026 · Official notice ↗
Product not adequately pasteurized
Official ID H-1093-2026 · Official notice ↗
Product not adequately pasteurized
Official ID H-1092-2026 · Official notice ↗
Product not adequately pasteurized
Official ID H-1091-2026 · Official notice ↗
Product not adequately pasteurized
Official ID H-1090-2026 · Official notice ↗
Product not adequately pasteurized
Official ID H-1089-2026 · Official notice ↗
Product not adequately pasteurized
Official ID H-1088-2026 · Official notice ↗
Product not adequately pasteurized
Official ID H-1087-2026 · Official notice ↗
Product not adequately pasteurized
Official ID H-1086-2026 · Official notice ↗
Product not adequately pasteurized
Official ID H-1085-2026 · Official notice ↗
Product not adequately pasteurized
Official ID H-1084-2026 · Official notice ↗
Product not adequately pasteurized
Official ID H-1083-2026 · Official notice ↗
Product not adequately pasteurized
Official ID H-1082-2026 · Official notice ↗
Product not adequately pasteurized
Official ID H-1081-2026 · Official notice ↗
Improperly eviscerated which may result in Clostridium botulinum contamination
Official ID H-1080-2026 · Official notice ↗
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Official ID D-0628-2026 · Official notice ↗
sub potency
Official ID D-0627-2026 · Official notice ↗
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Official ID D-0626-2026 · Official notice ↗
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Official ID D-0625-2026 · Official notice ↗
Non-Sterility: Due to presence of Aspergillus penicillioides.
Official ID D-0624-2026 · Official notice ↗
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Official ID D-0623-2026 · Official notice ↗
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Official ID D-0622-2026 · Official notice ↗
Lack of Assurance of Sterility
Official ID D-0621-2026 · Official notice ↗
Presence of foreign substance
Official ID D-0619-2026 · Official notice ↗
Incorrect product formulation: bag did not contain copper and famotidine per label.
Official ID D-0618-2026 · Official notice ↗
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Official ID D-0617-2026 · Official notice ↗
CGMP Deviations
Official ID D-0616-2026 · Official notice ↗
Presence of Foreign Substance.
Official ID D-0615-2026 · Official notice ↗
CGMP Deviations
Official ID D-0614-2026 · Official notice ↗
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Last checked July 23, 2026 at 9:51 PM UTC.