Browse Device Recalls
812 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 812 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 812 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. L... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-L... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case | Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. B... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case | Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC ... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | FEMORAL ARTERY PACK-LF. Sterile Procedural Tray | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | LOCAL PACK. Sterile Procedural Tray. | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. ... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOT... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 C... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS C... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| 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 |
| 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 |
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.