Hazard

Foreign Object Retention recalls

49 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 49
Critical: 0
Severe: 26
Most recent: 2020-10-28

Of the 49 foreign object retention recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 26 (53%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all foreign object retention recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–49 of 49

HighFDA (Devices)·Z-2143-2015·2015-07-29
DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Separation Risk
DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.
Product
ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation S
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2146-2015·2015-07-29
DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Separation Risk
DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.
Product
ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2145-2015·2015-07-29
DePuy ATTUNE Knee Trial Instrument Recall Due to Balseal Detachment Risk
DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.
Product
ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation S
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2141-2015·2015-07-29
DePuy ATTUNE Knee Trial Instrument Recall Due to Balseal Disassociation Risk
DePuy Orthopaedics is recalling ATTUNE RP CR Articulation Surface trial instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.
Product
ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surf
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2139-2015·2015-07-29
DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk
DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.
Product
ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Su
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2144-2015·2015-07-29
DePuy ATTUNE Knee Trial Instrument Recall for Balseal Detachment Risk
DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.
Product
ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to pro
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2140-2015·2015-07-29
DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk
DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient.
Product
ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2142-2015·2015-07-29
DePuy ATTUNE Knee Trial Instrument Recall Due to Balseal Detachment Risk
DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.
Product
ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-1437-2014·2014-04-16
DePuy Shoulder Guide Pin Recall Due to Breakage Risk
DePuy Orthopaedics is recalling 21,675 GLOBAL Anchor Peg Glenoid Plus 2.5mm Breakaway Guide Pins because they may break and be left in patients during surgery.
Product
GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product Usage: Usage: The GLOBAL APG+ 2.5mm Guide Pin is a single-use instrument that is used to assist the surgeon in the orientation of the cannulat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0419-2014·2013-12-04
DePuy Recalls Knee Instruments Due to Potential Tab Fracture
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs may fracture and remain in patients.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0416-2014·2013-12-04
DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
DePuy Orthopaedics is recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0412-2014·2013-12-04
DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0422-2014·2013-12-04
DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0420-2014·2013-12-04
DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0418-2014·2013-12-04
DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0414-2014·2013-12-04
DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0972-2013·2013-03-27
DePuy ReClaim Reamer Extension Recalled Due to Broken Tabs
DePuy Orthopaedics is recalling 750 ReClaim Reamer Extension devices because tabs may break and remain in patients during surgery.
Product
ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
Category
Medical Device
Distribution
27 states
SevereFDA (Devices)·Z-2480-2012·2012-10-10
Zimmer Recalls MIS Slotted Femoral Head Provisional Medical Devices
Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices due to reports of sub-optimal fit with mating components, which can lead to intraoperative dislodging.
Product
00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotte
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2475-2012·2012-10-10
Zimmer VerSys Provisional Femoral Heads Recalled for Fit Issues
Zimmer, Inc. is recalling VerSys provisional femoral heads due to reports of sub-optimal fit with mating components, which can cause intraoperative dislodging.
Product
00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14 Ne
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2479-2012·2012-10-10
Zimmer Recalls Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling specific provisional femoral heads used in hip surgery due to reports of improper fit with mating components.
Product
00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2481-2012·2012-10-10
Zimmer Recalls Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling MIS and VerSys provisional femoral heads due to reports of sub-optimal fit with mating components, which can lead to intraoperative dislodging.
Product
00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14 Slotte
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2478-2012·2012-10-10
Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling VerSys provisional femoral heads because complaints report sub-optimal fit with mating components, leading to intraoperative dislodging.
Product
12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2474-2012·2012-10-10
Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.
Product
00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14 Ne
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2477-2012·2012-10-10
Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.
Product
00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 12/14 Ne
Category
Medical Device
Distribution
Distributed nationwide