Browse Device Recalls

1,377 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,377 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 1,377 FDA device recalls.

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DateProductReasonClassFirm
May 28, 2026 Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTH... Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... Class II Medline Industries, LP
May 28, 2026 Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEA... Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... Class II Medline Industries, LP
May 28, 2026 Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CD... Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... Class II Medline Industries, LP
May 28, 2026 Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEA... Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... Class II Medline Industries, LP
May 28, 2026 Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL A... Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... Class II Medline Industries, LP
May 28, 2026 Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEAR... Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... Class II Medline Industries, LP
May 28, 2026 Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC M... Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... Class II Medline Industries, LP
May 28, 2026 Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMA... Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAI... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Numb... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: ... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590 The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215 The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number:... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN00... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO ... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710 The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; ... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number:... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 15, 2026 Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. ... Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of res... Class I Medline Industries, LP
May 6, 2026 Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2)... The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... Class I Medline Industries, LP
May 6, 2026 Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ... The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... Class I Medline Industries, LP
May 6, 2026 Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: AC... The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... Class I Medline Industries, LP
May 6, 2026 Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROO... The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... Class I Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT,... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline ... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Num... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Num... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline ... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SK... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot C... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Numb... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medli... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF)... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Nu... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Num... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTER... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, M... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/S... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medl... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Me... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Num... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP

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.