Browse Device Recalls

261 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 261 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 261 FDA device recalls.

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Date	Product	Reason	Class	Firm
Oct 6, 2016	11cm QD Angle Attachment Product Usage: Pneumatic system	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, Inc.
Oct 6, 2016	STANDARD CRANIOTOME, BLACK MAX	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, Inc.
Oct 6, 2016	Foot Control without Switches, SC2100 Product Usage: Electric system	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, Inc.
Oct 6, 2016	Rotating Adult Craniotome Product Usage: Pneumatic system	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, Inc.
Oct 6, 2016	12.6CM TAPERED ATTACHMENT, BLACK MAX Product Usage: Pneumatic system	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, Inc.
Oct 6, 2016	XMAX Motor, High Strength Hose Product Usage: Pneumatic system	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, Inc.
Oct 6, 2016	14cm QD Angle Attachment Product Usage: Product attachment	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, Inc.
Oct 6, 2016	IMRI AIR CONTROL Product Usage: Pneumatic system	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, Inc.
Oct 6, 2016	SMALL ATTACHMENT, J-LATCH	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, Inc.
Oct 6, 2016	6.8cm Controlled Depth Attachment Product Usage: Pneumatic system	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, Inc.
Oct 6, 2016	Electric Handpiece EM Hand Control Product Usage: Electric system	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, Inc.
Oct 6, 2016	14cm QD Angle Attachment Product Usage: Pneumatic system	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, Inc.
Oct 6, 2016	Keyless Driver Product Usage: Pneumatic system	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, Inc.
Aug 26, 2016	G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spin...	Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products wer...	Class II	The Anspach Effort, Inc.
Aug 26, 2016	G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping...	The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Ho...	Class II	The Anspach Effort, Inc.
Aug 26, 2016	G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including ...	The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Ho...	Class II	The Anspach Effort, Inc.
Aug 26, 2016	G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping...	The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Ho...	Class II	The Anspach Effort, Inc.
Jun 24, 2016	Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage:...	There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery...	Class I	The Anspach Effort, Inc.
Jun 24, 2016	Light Adaptor for Small Battery Drive and Small Battery Drive II.	There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery...	Class I	The Anspach Effort, Inc.
Jun 15, 2016	Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting...	The graphics at the attachment interface indicating locked and unlocked position are reversed.	Class II	The Anspach Effort, Inc.
Mar 28, 2016	ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Par...	Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coa...	Class II	The Anspach Effort, Inc.
Mar 28, 2016	ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Par...	Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coa...	Class II	The Anspach Effort, Inc.
Jan 15, 2016	Universal Battery Charger II (UBC II)	The device is reported to enter safe mode and is no longer able to charge batteries.	Class II	The Anspach Effort, Inc.
Nov 25, 2015	Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Ansp...	Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, R...	Class II	The Anspach Effort, Inc.
Nov 2, 2015	Irrigation Clip 30; Intended to position and hold irrigation tubing during su...	Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498).	Class II	The Anspach Effort, Inc.
Jul 1, 2015	Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical p...	Saw head separated from the drive unit or began to come loose.	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting s...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shapi...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bon...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1. Cutting sh...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. C...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cut...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cut...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - 6MM x 11.3MM Fluted Barrel; REF M-6BA-A-G1 Cutting shaping bon...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - 7MM Extra Coarse Diamond Ball; REF M-7DX-G1 Cutting shaping bo...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone ...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting sha...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM REF L-9DRC-G1 Cutting ...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutti...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - 7MM Fluted Acorn; REF M-7AC-G1 Cutting shaping bone including ...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shapin...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cu...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 ...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-G1. Cutting ...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including sp...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting ...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, Inc.
Apr 13, 2015	ANSPACH - 5MM Fluted Ball, Extends 27MM; REF M-5B-27-G1. Cutting shapin...	G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t...	Class II	The Anspach Effort, 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.