Browse Device Recalls

38 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 38 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 38 FDA device recalls.

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Date	Product	Reason	Class	Firm
Oct 29, 2024	BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.	Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the...	Class II	Smith & Nephew Inc.
Oct 2, 2024	smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 L...	Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant inst...	Class II	Smith & Nephew Inc
Oct 2, 2024	smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZ...	Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implan...	Class II	Smith & Nephew Inc
Oct 2, 2024	smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT,...	Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implan...	Class II	Smith & Nephew Inc
Oct 2, 2024	smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 L...	Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant inst...	Class II	Smith & Nephew Inc
Aug 12, 2024	ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation ...	Product packaging process may result in an improper or incomplete seal of the outer foil pouch su...	Class II	Smith & Nephew Inc.
Aug 12, 2024	ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixatio...	Product packaging process may result in an improper or incomplete seal of the outer foil pouch su...	Class II	Smith & Nephew Inc.
May 24, 2024	WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation flu...	Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set...	Class II	WOM World Of Medicine AG
Apr 24, 2024	smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Ste...	Packaging contained the incorrect size of femoral head from what was displayed on the label.	Class II	Smith & Nephew Inc
Aug 31, 2023	smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, ...	The firm conducting a recall due to a complaint received indicating that a package contained a LE...	Class II	Smith & Nephew Inc
Apr 19, 2022	LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5	It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARRO...	Class II	Smith & Nephew Inc
Apr 4, 2014	TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT...	A manufacturing error resulted in the set screw being inserted too deep in the affected nails.	Class II	Smith & Nephew Inc
Apr 4, 2014	TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) RE...	A manufacturing error resulted in the set screw being inserted too deep in the affected nails.	Class II	Smith & Nephew Inc
Jan 23, 2014	Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, ...	Inner spherical radius of the shell is undersized.	Class II	Smith & Nephew Inc
Jan 9, 2014	Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS So...	Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ...	Class II	Smith & Nephew Inc.
Jan 9, 2014	Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934...	Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ...	Class II	Smith & Nephew Inc.
Jan 9, 2014	Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s:...	Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ...	Class II	Smith & Nephew Inc.
Jan 9, 2014	Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794...	Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ...	Class II	Smith & Nephew Inc.
Jan 9, 2014	Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dress...	Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ...	Class II	Smith & Nephew Inc.
Jan 9, 2014	Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 668...	Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ...	Class II	Smith & Nephew Inc.
Nov 25, 2013	REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-5...	One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing th...	Class II	Smith & Nephew Inc
Nov 14, 2013	Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Th...	Modification of the bacterial overflow guard (filter) and related changes to product labeling.	Class II	Smith & Nephew Inc.
Nov 14, 2013	Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wou...	Modification of the bacterial overflow guard (filter) and related changes to product labeling.	Class II	Smith & Nephew Inc.
Oct 7, 2013	GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. ...	Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.	Class II	Smith & Nephew Inc
Oct 7, 2013	GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188....	Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.	Class II	Smith & Nephew Inc
Aug 27, 2013	GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), R...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 27, 2013	GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), ...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 27, 2013	GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), R...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 27, 2013	GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), R...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 27, 2013	GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), RE...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 27, 2013	GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Jul 8, 2013	GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM...	The products were produced using the wrong color material, resulting in the devices being red (u...	Class II	Smith & Nephew Inc
May 29, 2013	R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: ...	One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and on...	Class II	Smith & Nephew Inc
May 29, 2013	R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: ...	One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and on...	Class II	Smith & Nephew Inc
Mar 6, 2013	TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF ...	One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold...	Class II	Smith & Nephew Inc
Feb 7, 2013	INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAP...	75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm scre...	Class II	Smith & Nephew Inc
Feb 7, 2013	INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAP...	75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm scre...	Class II	Smith & Nephew Inc
Aug 22, 2012	12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL ...	Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.	Class II	Smith & Nephew 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.