Browse Device Recalls

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

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Date	Product	Reason	Class	Firm
Aug 11, 2021	LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Mo...	Stretch Leveller has the potential to lose the function of maintaining a patient in the horizonta...	Class II	Hill-Rom, Inc.
Aug 11, 2021	SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical ...	When using manual mode, the tabletop may not completely move in or out and result in potential de...	Class II	Philips North America Llc
Aug 11, 2021	Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for...	When using manual mode, the tabletop may not completely move in or out and result in potential de...	Class II	Philips North America Llc
Aug 10, 2021	Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for us...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: si...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outloo...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are inten...	Software: A coding error associated with the Fast3D Segmentation software. During the scanning p...	Class II	DePuy Orthopaedics, Inc.
Aug 10, 2021	TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intend...	Software: A coding error associated with the Fast3D Segmentation software. During the scanning p...	Class II	DePuy Orthopaedics, Inc.
Aug 10, 2021	TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intend...	Software: A coding error associated with the Fast3D Segmentation software. During the scanning p...	Class II	DePuy Orthopaedics, Inc.
Aug 10, 2021	Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion ...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infus...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infus...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with th...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety ...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	REGARD Stereotactic Tray	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use...	Class II	ROi CPS LLC
Aug 10, 2021	Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intend...	Software: A coding error associated with the Fast3D Segmentation software. During the scanning p...	Class II	DePuy Orthopaedics, Inc.
Aug 10, 2021	60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	REGARD Ultrasound Tray	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use...	Class II	ROi CPS LLC
Aug 10, 2021	REGARD Core Biopsy Tray	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use...	Class II	ROi CPS LLC
Aug 10, 2021	Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook ...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	REGARD Newborn Tray	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use...	Class II	ROi CPS LLC
Aug 10, 2021	OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Saf...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are inte...	Software: A coding error associated with the Fast3D Segmentation software. During the scanning p...	Class II	DePuy Orthopaedics, Inc.
Aug 10, 2021	OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administ...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with th...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for u...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safet...	Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm...	Class II	B. Braun Medical, Inc.
Aug 10, 2021	REGARD Basic Cataract tray	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use...	Class II	ROi CPS LLC
Aug 10, 2021	TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intend...	Software: A coding error associated with the Fast3D Segmentation software. During the scanning p...	Class II	DePuy Orthopaedics, Inc.
Aug 10, 2021	TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intend...	Software: A coding error associated with the Fast3D Segmentation software. During the scanning p...	Class II	DePuy Orthopaedics, Inc.
Aug 10, 2021	REGARD Ear Tray	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use...	Class II	ROi CPS LLC
Aug 10, 2021	REGARD Vitrectomy Tray	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use...	Class II	ROi CPS LLC
Aug 9, 2021	Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connect...	Incorrect version of labels were used.	Class II	Ad-Tech Medical Instrument Corporation
Aug 9, 2021	Bivona Uncuffed Wire Endotracheal Tubes,	Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of...	Class II	Smiths Medical ASD Inc.
Aug 9, 2021	Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of...	Incorrect version of labels were used.	Class II	Ad-Tech Medical Instrument Corporation
Aug 9, 2021	Bivona Aire-Cuf Endotracheal Tube	Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of...	Class II	Smiths Medical ASD Inc.
Aug 9, 2021	DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressin...	There is a potential for open seals which can compromise sterility.	Class II	ConvaTec, Inc
Aug 9, 2021	Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay Sy...	Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,0...	Class II	Beckman Coulter Inc.
Aug 9, 2021	Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpo...	Incorrect version of labels were used.	Class II	Ad-Tech Medical Instrument Corporation
Aug 6, 2021	Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat...	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing	Class II	ZOLL Circulation, Inc.
Aug 6, 2021	Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Cathete...	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing	Class II	ZOLL Circulation, Inc.
Aug 6, 2021	Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Cath...	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing	Class II	ZOLL Circulation, Inc.
Aug 6, 2021	Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Cathe...	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing	Class II	ZOLL Circulation, Inc.
Aug 6, 2021	Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Ki...	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing	Class II	ZOLL Circulation, Inc.
Aug 6, 2021	NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF ...	Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potent...	Class II	Medline Industries Inc
Aug 6, 2021	Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start ...	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing	Class II	ZOLL Circulation, Inc.
Aug 6, 2021	Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP K...	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing	Class II	ZOLL Circulation, Inc.
Aug 6, 2021	Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP ...	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing	Class II	ZOLL Circulation, Inc.

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.