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
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 12, 2023 Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000 The scissors were manufactured without a tip protector resulting in the scissors breaking through... Class II MEDLINE INDUSTRIES, LP - Northfield
May 3, 2023 MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b)... Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a st... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2023 Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (... The kits were damaged by water. Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 28, 2023 DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration da... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 2, 2023 Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Ste... The CirClamp subassembly found in the kit was the incorrect size. Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 27, 2022 (1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per ca... The convenience trays had improper placement of some of the components that were in the nonsteril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 27, 2022 Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits p... The convenience trays had improper placement of some of the components that were in the nonsteril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 27, 2022 (1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD ... The convenience trays had improper placement of some of the components that were in the nonsteril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 23, 2022 CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760 The kit contained an expired component. Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 22, 2022 MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF M... The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill b... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 22, 2022 MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008 The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill b... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 22, 2022 MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013 The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill b... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRA... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reo... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Num... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Nu... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUM... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISI... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOM... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST T... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder N... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRA... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJ... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYND... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PI... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... 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.