Browse Device Recalls

1,001 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,001 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,001 FDA device recalls.

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DateProductReasonClassFirm
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATIO... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 30, 2022 BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical ... Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 30, 2022 BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgic... Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 30, 2022 MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical ... Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 30, 2022 BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgic... Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 30, 2022 BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical pr... Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 30, 2022 BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical ... Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 30, 2022 MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical ... Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 30, 2022 BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgic... Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 30, 2022 BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used i... Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 30, 2022 MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in me... Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 30, 2022 MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical proc... Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 30, 2022 MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures. Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 30, 2022 CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Conv... Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 9, 2022 MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632 Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 9, 2022 MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592 Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 9, 2022 MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756 Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 9, 2022 MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561 Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 9, 2022 MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245 Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 7, 2022 CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545 One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 1, 2022 VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular proc... Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #1... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2022 MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 1... Potential for the suction catheter to come apart from the green connector near the thumb valve. T... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2022 MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch... Potential for the suction catheter to come apart from the green connector near the thumb valve. T... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2022 MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 1... Potential for the suction catheter to come apart from the green connector near the thumb valve. T... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 29, 2022 MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351... stability failure Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 6, 2022 Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ068909... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE M... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, ... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT ... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRA... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B,... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Numb... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
May 11, 2022 Medline Pill Splitters; 1 each/box; 144 boxes/carton Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade. Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2022 MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2022 MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2022 MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2022 MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2022 MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 9, 2022 Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box The mask cuff may disconnect from the device's breathing tube. Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 8, 2022 Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8... Product was improperly store which may cause a delay in results. Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 8, 2022 Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes conta... The product was stored incorrectly due to improper storage controls which may lead to delayed res... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 4, 2022 Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride In... Sterility failure of the exterior of the syringe which may impact the device's ability to be laid... Class II MEDLINE INDUSTRIES, LP - Northfield
Jan 25, 2022 meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit... The product was incorrectly shipped at room temperature rather than refrigerated. Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 29, 2021 MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite. Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 15, 2021 CURAD REUSABLE GEL HOT/COLD PACK The product contains natural rubber latex but the label states that it does not. Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 1, 2021 Michels Transport Medium, 20ML Prefilled Cont Product stored incorrectly in temperature controlled setting instead of refrigeration. Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 1, 2021 Premier Rotaclone, Rx only Product stored incorrectly in temperature controlled setting instead of refrigeration. Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 1, 2021 HARDY DIAGNOSTICS CatScreen, 25dsk/vial Product stored incorrectly in temperature controlled setting instead of refrigeration. Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 30, 2021 Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605 Affected product was shipped from the warehouse at room temperature instead of the required refri... Class II MEDLINE INDUSTRIES, LP - Northfield

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.