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.

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DateProductReasonClassFirm
Mar 22, 2024 LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500 A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 14, 2024 Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack ... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 14, 2024 Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, con... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 14, 2024 Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, cont... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 14, 2024 Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure,... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 14, 2024 Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, co... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 14, 2024 Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack ... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 14, 2024 Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C,... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 14, 2024 Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, ... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 14, 2024 Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYN... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 12, 2024 namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIF... Products have a lack of sterility assurance. Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 12, 2024 Namic FLUID DELIVERY SET, REF 91300040 Products have a lack of sterility assurance. Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 5, 2024 Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Numb... Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after th... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 5, 2024 Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b)... Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after th... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 1, 2024 Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray Trumpet Needle Guide ring can detach when excessive pressure is applied. Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 1, 2024 Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TR... Trumpet Needle Guide ring can detach when excessive pressure is applied. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 26, 2024 Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS40... The firm provided a set of specifications for the device, but some units of the device were manuf... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 26, 2024 Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18... Complaints have been received that the device inflation tube detached and/or tore from the main t... Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Pro... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697)... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP,... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6"... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product ... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505 Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Pr... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE C... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion STERILE TRACH BRUSH, Product Code 6225ST Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion PICC LINE SECUREMENT KIT, Product Code IVS565 Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006 Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), P... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575 Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430ST Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830 Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", P... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723 Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), ... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST718... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion STERILE #16 RUBBER BAND, Product Code EB16 Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724 Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6 Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335 Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (S... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Jan 23, 2024 CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate packa... Product failed sterility testing. Class II MEDLINE INDUSTRIES, LP - Northfield
Jan 4, 2024 Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testin... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023 MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... 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.